Cleared Traditional

SpeediCath Flex Set (K222059) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222059 · Coloplast · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
70d
Days
Class 2
Risk

K222059 is an FDA 510(k) clearance for the SpeediCath Flex Set. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Coloplast (Plymouth, US). The FDA issued a Cleared decision on September 21, 2022 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Coloplast devices

Submission Details

510(k) Number K222059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2022
Decision Date September 21, 2022
Days to Decision 70 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 130d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZD Catheter, Straight
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - EZD Catheter, Straight

All 42
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K222059.
PVC Hydrophilic Urethral Catheter
K212567 · Chengdu Daxan Innovative Medical Tech. Co., Ltd. · Dec 2022
Self-Cath and Self-Cath Plus
K221401 · Coloplast · Dec 2022
Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus
K221593 · Convatec, Inc. · Nov 2022
Female IC (Not Finalized)
K213575 · Hollister Incorporated · Sep 2022
BONREE Nelaton Catheter
K212430 · Bonree Medical Co., Ltd. · Apr 2022
SpeedCath Compact Male
K210250 · Coloplast · Apr 2022